Things go better with Burch

Are subjective or objective measures better?

• Subjective measures convey a patient’s foremost concerns and how she is doing clinically
  
• Correlating symptoms with objective measures yields valuable insights into treatment
  

KOHLI: The CARE trial uses both objective and subjective measures of incontinence. Which do you think are most important?

BRUBAKER: I prefer subjective measures because I think they reflect what is most important to patients in quality-of-life disorders. However, I believe we need to understand the relationship between subjective outcomes and traditional “objective” outcomes.

WEBER: I think the research community is reaching a consensus that “subjective” measures—better described as patient-oriented outcomes—are more important than objective measures, particularly for conditions that affect patients in “subjective” ways, ie, ways that affect their health-related quality of life, rather than quantity of life. This does not mean that objective measures are useless—although we should first evaluate each measure critically to make that determination on the basis of evidence.

Nevertheless, when a patient seeks and receives treatment based on symptoms and how those symptoms impact her daily life, I think it is incumbent upon researchers and clinicians to ensure that the treatment that is considered most effective actually results in a change that the patient finds worthwhile.

What is “success”?

WALTERS: When it comes to incontinence, for which there is an imperfect correlation between various objective and subjective measures, I think both types of measures are valuable and important. Gathering several different types of outcomes for each patient helps us better understand the nuances of how well an intervention works.

I can understand why some clinicians and researchers place greater reliance on subjective measures of incontinence, such as a diary of incontinence episodes and quality-of-life measures, because these measures tell us exactly how the patient is doing clinically and how she feels about the intervention. If she reports that she is completely cured and “perfect,” then objective measures are irrelevant. However, for any subjective outcome short of perfect, correlation with the objective measures such as cough stress test, physical examination, and urodynamic tests can help investigators understand the reason for the imperfect outcome and point to areas of possible improvement.

KOHLI: In my practice, some women who continue to leak slightly after an incontinence procedure consider their surgery a complete success, whereas, as a surgeon, I consider it a suboptimal result. Both objective and subjective results are important.

Putting the CARE trial into practice

• Data relate directly only to women undergoing abdominal sacrocolpopexy
  
• Patient education, medicolegal, and reimbursement may also relate
  
• Results reflect the high prevalence of pelvic floor disorders and the need to routinely ask about them
  

KOHLI: How will the CARE trial findings affect your clinical practice?

BRUBAKER: I routinely counsel patients who are planning sacrocolpopexy but who do not have stress incontinence to consider a concomitant Burch procedure. I do not have them undergo urodynamic testing because, at this time, the results of that testing would not change my clinical practice.

WALTERS: I have always been liberal when it comes to adding retropubic colposuspension to abdominal sacrocolpopexy, even in women who do not have preoperative stress incontinence. The reason? Patients who are continent preoperatively, but become stress-incontinent postoperatively, are particularly unhappy with their outcome, especially if they need another surgery within a year to treat the stress incontinence. So this study verified what I was already doing.

What I didn’t learn is whether a paravaginal defect repair helps or hurts the Burch procedure from an anatomic and functional perspective.

It also appears that preoperative urodynamic testing has little value, although that was not the point of this study. I am glad it will be addressed in future studies.

KOHLI: I think the findings apply to those select patients undergoing abdominal sacrocolpopexy for prolapse. It would be dangerous to extrapolate these results to other abdominal vault suspension procedures or vaginal prolapse procedures. Based on the CARE trial, I plan to counsel patients about the risks and benefits of “optional” Burch colposuspension at the time of planned sacrocolpopexy. In reality, however, I have almost completely switched to minimally invasive midurethral slings, even in the case of abdominal prolapse procedures, because of their high cure rates, low complication rates, and ease of postoperative adjustment.

Clinical implications depend on surgeon’s routine

KOHLI: What are the implications for the majority of ObGyns?

WEBER: It depends on what ObGyns are doing for women with prolapse.

For ObGyns who are confident and competent, through training and experience, to perform abdominal sacrocolpopexy for women with advanced prolapse, the CARE trial results have a direct effect. Women with prolapse who are stress continent with no contraindications, can be reassured that they will benefit from a 50% reduction of postoperative stress incontinence with the Burch procedure.